MAUDE Adverse Event Report: MEDICHOICE M500812 ULTRASOUND GEL; MEDIA, COUPLING, ULTRASOUND

Patient Problem Foreign Body Reaction (1868)

Event Date 09/11/2023

Event Type  Injury  

Event Description

Have concerns that office may be using the medichoice m500812 ultrasound gel or a similar product that may be contaminated.Both under (b)(6) hospital.Each time they used gel and inserted an object my condition worsened.Have not found the cause after multiple tests.Still having health issues four weeks later and no one knows what's wrong with me.Assuming same gel each time as same hospital system.Issues began within hours of initial pelvic exam and worsened after ultrasound.Ref report: mw5146980.

• Brand Name: MEDICHOICE M500812 ULTRASOUND GEL
• Type of Device: MEDIA, COUPLING, ULTRASOUND
• MDR Report Key: 17949196
• MDR Text Key: 326021138
• Report Number: MW5146979
• Device Sequence Number: 1
• Product Code: MUI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 52 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White